PROTOCOL REVIEW AND MONITORING SYSTEM Project Summary The goal of the Protocol Review and Monitoring System (PRMS) at the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) is to provide systematic internal review and oversight of all cancer-related studies without duplicating traditional peer review. The Specific Aims of the PRMS are to 1) prioritizing all cancer clinical trials, regardless of source, proposed to be conducted at Wake Forest Baptist Medical Center; 2) reviewing the scientific merit of all investigator-initiated cancer clinical trials proposed to be conducted at Wake Forest Baptist Medical Center; and 3) conducting ongoing review of study accrual and scientific progress of WFBCCC clinical trials. The PRMS process is supported by Disease-Oriented Teams, the Operations Protocol Service, the Protocol Review Committee, and the Clinical Research Oversight Committee. Cancer-related protocols thus are initially developed by Disease-Oriented Team concept review, prioritized within the Disease- Oriented Team portfolio, and then reviewed by the Operations Protocol Service for logistical considerations and the Protocol Review Committee for scientific merit and final prioritization. Monitoring of accrual and scientific progress, including biostatistical reports and interim endpoint analyses, are carried out by the Clinical Research Oversight Committee, with Disease-Oriented Team support. In the most recent grant year, 111 trials were reviewed by the Protocol Review Committee and 280 trials were monitored by the Clinical Research Oversight Committee.